MAUDE Adverse Event Report: RICHARD WOLF GMBH COBRA; FIBER-URETERORENOSCOPE 9.9FR WL 680MM FLEXIBLE

Model Number 7326071

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

Rwmic will reach out to the user facility and the manufacturer to gather additional information.Upon receipt of new information, a follow-up report will be submitted.

Event Description

It was reported that the device was "inserted into penis and while inside it fell apart.They had to go back in and retrieve what parts they could find.Caused delay and possible harm to patient since they don't know if they retrieved all the parts.Rwr-6/1/20 new 12/12/16 they were using a laser during the procedure.The initial reporter called back later and confirmed they didn't use a laser when this was inside the patient.They used it afterwards.The initial reporter also reported on the medwatch questionnaire: potential patient harm due to black covering at the scope tip sloughing off inside of patient's ureter.Small black pieces retrieved.Scope handed off sterile field to spd cnoic.Will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? yes.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.

Event Description

Follow-up report #1 is to provide fda with missing information, new information and/or changed information.Please refer to the manufacturer's narrative for details.

Manufacturer Narrative

Follow-up report #1 is to provide fda with missing information, new information, and changed information.New information: device was returned to rwmic and evaluation was conducted, (b)(6) 2020, using visual and functional testing.The reported condition - device when inserted into the patient fell apart: was confirmed during evaluation.The probable root cause is reprocessing and user error.Findings of the investigation conclude that the shaft of the scope was damaged due to reprocessing and the head damaged by laser.Changed information: the following fields have changed information: b5, d10, f1, g7, h6, h7, and h10.Device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed.The ifu contains cautions and warnings about using the device.The ifu also contains handling instructions during reprocessing.Caution! failure to observe can result in slight injury or damage to the product.Important: failure to observe can result in damage to the product or surroundings high temperatures due to highly coherent laser beam! the heat generated by the laser beam reduces the strength of instrument parts.Do not direct the laser beam at instrument parts, in particular not at plastic parts.Keep a safe distance.Danger of destroying the instrument by laser energy! important general notes and instructions: use the product only in the combinations and with the accessories and spare parts specified in this instruction manual.Use other combinations, accessories and replacement parts only if they are expressly intended for the planned applic­ation and if the performance characteristics and safety requirements are not impaired.Do not alter the product in any way.Handling during reprocessing: safe storage and transport of the endoscope to the reprocessing room in a closed container to prevent damage to the endoscope and contamination of the environment.Rwmic considers this mdr closed.Follow-up reports will be sent to the fda if new information is received.Attachment: [ga-d347 usa_7.0 (13-0236).Pdf, ga-j050 usa_5.0 (13-0221).Pdf].

• Brand Name: COBRA
• Type of Device: FIBER-URETERORENOSCOPE 9.9FR WL 680MM FLEXIBLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10397455
• MDR Text Key: 202693489
• Report Number: 1418479-2020-00020
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04055207013748
• UDI-Public: 04055207013748
• Combination Product (y/n): N
• PMA/PMN Number: K183188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7326071
• Device Catalogue Number: 7326071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Distributor Facility Aware Date: 08/07/2020
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2020
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 84